MAUDE Adverse Event Report: LIMACORPORATE SPA SMR HUMERAL HEAD D.50 H.16MM; HUMERAL HEADS (COCRMO) - DIA.50MM H.16

Model Number 1322.09.501

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Joint Dislocation (2374)

Event Date 09/10/2021

Event Type  Injury  

Event Description

Shoulder revision surgery due to instability and luxation performed on (b)(6) 2021.The primary surgery took place on (b)(6) 2021.According to the information received, the suboptimal positioning of the components contributed to cause the revision surgery.During the revision surgery, the following components were explanted: stemless core 1355.14.238 lot 2104845 ster.2100173, adaptor 1335.15.202 lot 1819665 ster.1900025, hybrid glenoid 1379.59.110 lot 2108898 ster.2100159, humeral head 1322.09.501 lot 1900161 ster.1900049.Smr stemless anatomic implant with axioma tt metal back and tt peg was then implanted.A further revision surgery (conversion to smr stemless reverse) was subsequently performed on (b)(6) 2021, due to repeated dislocation.According to the received information, the cause of the second revision surgery was patient's behavior, as he was not compliant to the post-operative care due to alcoholism.The second revision surgery was registered as complaint (b)(4), not reported to the competent authority as it was caused by patient's actions.This incident occurred in (b)(6).Note: the stemless system is not cleared in usa, among the abovementioned product codes, only the humeral head and the hybrid glenoid are cleared in the usa (smr anatomic system).

Manufacturer Narrative

The device history records of the involved components were checked with the following results: no pre-existing anomaly detected on the 14 smr stemless cores that belong to product code 1355.14.238, lot 2104845 ster.2100173, no pre-existing anomaly detected on the 35 adaptors that belong to product code 1335.15.202, lot 1819665, ster.1900025, no pre-existing anomaly detected on the 15 hybrid glenoids that belong to product code 1379.59.110, lot 2108898, ster.2100159, no pre-existing anomaly detected on the 10 humeral heads that belong to product code 1322.09.501, lot 1900161, ster.1900049, limacorporate is not aware of other complaints on these lot numbers.The explanted components were not returned to limacorporate for analysis.The following x-rays were received by limacorporate and analyzed by a medical consultant: pre-operative x-rays of the first revision surgery ((b)(6) 2021), two different views, pre-operative and post-operative x-rays of the second revision surgery ((b)(6) 2021), two different views each.The medical consultant commented: "the pre-revision 1st radiographs show postero-superior dislocated humeral head due to rotator cuff failure.Pre 2nd revision the same: the head is dislocated postero-superiorly, this can only happen with an insufficient rotator cuff.Pos-revision 2nd radiographs look unremarkable.This is a fateful cause of events after primary implantation and not an implant related problem." in conclusion: the explanted components were not returned to limacorporate for a specific analysis, the production documents confirmed the absence of pre-existing anomaly on the involved components, thus we can state they had been manufactured up to drawing specifications and in line with the relevant checks, the complaint source reported that the cause of the revision surgery object of this report might be related to suboptimal positioning of the components, according to the information received, the patient is an alcoholic, and this condition was the cause of not compliant behavior leading to the second revision surgery, the medical consultant analyzed the available x-rays without detecting any implant-related issue, however, he did not confirm the suboptimal positioning reported by the complaint source.Based on the analyses performed, we cannot determine with certainty the cause of the first revision surgery performed on this patient, however, we classify this event as not product-related.Pms data pms data are provided with reference to the anatomic configuration of the smr system (the stemless system is in fact not cleared in the usa), based on limacorporate pms data, we estimate a revision rate due to implant dislocation/luxation of about 0.12%.No corrective action is needed following this complaint.Limacorporate will continue monitoring the market to promptly detect any further similar event.Note: please consider this report an initial-final combined mdr.

• Brand Name: SMR HUMERAL HEAD D.50 H.16MM
• Type of Device: HUMERAL HEADS (COCRMO) - DIA.50MM H.16
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 14185128
• MDR Text Key: 294641950
• Report Number: 3008021110-2022-00027
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K161476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1322.09.501
• Device Lot Number: 1900161
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention